Catheter kit for a urinary catheter

ABSTRACT

A urinary catheter kit is provided. The catheter kit includes a catheter with a flared end and a package provided with interior protrusions for cooperating with the flared end of the catheter. The largest outer diameter of the flared end of the catheter is slightly larger than the smallest diameter of the package at the protrusions. Thereby, the protrusions will function as a backstop for the catheter. The rigidity of the catheter at the flared end is selected so that—depending on the angle of the flared end—the flared end will be able to flip over if it is subjected to a force over a predetermined level. Thereby the catheter will be able to be entered back into the package.

The invention relates to a catheter kit for a urinary cathetercomprising a package and a urinary catheter. The urinary catheter isprovided with a flared end and the package is provided with interiorprotrusions adapted for cooperating with the flared end.

BACKGROUND

Urinary catheters are used as a tool assisting in the draining of theurinary bladder of persons that have reduced or non-existing bladdercontrol. The reduced or non-existing bladder control may either betemporary or permanent, where a temporary loss of bladder control may becaused by for example trauma, loss of consciousness or illness. Anexample of a permanent loss of bladder control may be where a loss of aneural connection between the brain or spinal cord and the urinarybladder occurs due to a trauma to the spinal cord, as is often the casewith para- and tetraplegics.

One example of a urinary catheter which is widely used for drainingurine from the urinary bladder, is where a catheter tube is insertedinto the urethra of a user and where the tip of the catheter tube ismaneuvered into the urinary bladder, forcing the urethral sphincter openand thus providing a drainage channel from the urinary bladder and outof the body, via the catheter tube. There are two types of catheterswhich are commonly used, the permanent catheter and the intermittentcatheter. The permanent catheter is a highly flexible catheter which isinserted by medical professionals into the body for a long period oftime, up to 12 weeks, and where the catheter is anchored inside thebladder. The intermittent catheter is usually a single use catheter or amultiple use catheter, which is inserted by the user into theurethra/bladder for the immediate drainage of their urinary bladder andis removed from the urethra/bladder following the drainage. Thefollowing disclosure will primarily be concentrated on the intermittenturinary catheter.

DESCRIPTION OF RELATED ART

There are a number of different types of intermittent catheters whichare currently available for the user, such as SpeediCath™ and EasiCath™marketed by Coloplast A/S. These are conventional one-piece cathetertubes which have an outlet at their distal end that may be used toconnect the catheter to a urinary bag for collecting the urine drainedfrom the urine bladder.

Another type of a catheter is disclosed in WO 03/002179 which is atelescopic catheter, where one of the telescopic elements is thecatheter package and another telescopic element is the catheter memberthat telescopes from the catheter package. The telescopic catheter iscollapsed during storage and transport and extended for insertion intothe urethra, providing female users with a compact and discrete catheterwhich may be used anywhere and without any significant preparation time.

Another type of catheter is disclosed in WO 2008/138351 which disclosesa telescopic device having a first tubular member and an extensionmember having a coupling member that limits the displacement of theextension member within the first tubular member, where the couplingmember engages the interior of the first tubular member. This device isa telescopic intermittent catheter, which is also adapted for the use bya male user, where the first tubular member is adapted in such a waythat both telescopic members are adapted to be inserted into the urethraof the user.

The telescopic catheters known in the art, as discussed above, arelocked in their extended state, such that the extension member or thetelescopic element is prevented from collapsing into their compactedstate. This means that upon disposal of the catheter, possibly afteruse, either into a trash bin or back into a storage area, such as ahandbag or a pocket, it is difficult to dispose of the catheterdiscretely.

Thus, there is a need for a telescopic device that, during extension,can be prevented from collapsing. Furthermore, the device may becollapsed into a collapsed state.

SUMMARY OF THE INVENTION

The invention concerns a urinary catheter kit including a package and acatheter. The catheter has a flared end and the package has ribs orother protrusions extending inwards in the package. The flared end isadapted in its outermost diameter to cooperate with the smallestdiameter between the ribs or protrusions of the package. In the originalconfiguration, the outermost diameter of the flared end is in the end ofthe catheter farthest away from the tip, that is the distal end of thecatheter. Thereby, when the flared end is subjected to a pushing forcein the direction opposite the removal direction of the catheter from thepackage, the flared end will be caught against a rib or protrusion inthe package. If the pushing force exceeds a predetermined level, theflared end will be adapted to fold around itself so it faces in theopposite direction. In this position, the catheter will be able to bepushed back into the package almost without resistance. However acertain pulling force will be needed to unfold the flared end to theoriginal configuration.

DETAILED DESCRIPTION OF THE INVENTION

In a first aspect, the invention relates to a urinary catheter kitcomprising

-   -   a package for a catheter having a storage space adapted for        storing the catheter    -   a urinary catheter having a proximal end with a tip and a distal        flared end, where the tip is adapted for being inserted through        the urethra and all the way into the bladder of the user, and        the flared end is adapted for being connected to a tube for        leading urine away from the catheter,    -   the storage space being generally tubular and being provided        with interior protrusions defining a smallest diameter of the        storage space at the protrusions,    -   the flared end having a largest diameter of the catheter larger        than the diameter of an insertable part of the catheter,    -   wherein the largest diameter of the catheter is larger than the        smallest diameter of the storage space.

A urinary catheter kit as mentioned above, will be able to prevent thecatheter from being pushed back into the storage space of the package.Thereby, the catheter kit will clearly indicate whether it has been usedor not. Furthermore, the package will be able to function as backstopwhen the catheter is inserted into the urethra.

The package can be made in a number of configurations. In oneembodiment, the package is made of a material that is gas impermeable.If a liquid swelling medium is provided inside the package, it may beadvantageous that the package is made of a gas impermeable material,such that any diffusion of the liquid swelling medium is reduced orprevented and the catheter may be maintained in a wetted condition for asignificant time period. A significant time period may for example bethe shelf-life of the urinary catheter kit, which may be a period ofapproximately 6 months to approximately 5 years. An example of amaterial suitable for use is Polyethylene (PE).

In one embodiment, the storage space is shaped as a spiral. In otherwords, the storage space of the package is helical and may be shaped asan Archimedes spiral. This type of package makes a very compact catheterkit that is easy to carry along and keep in a handbag, a pocket or thelike.

In another embodiment the package is elongated. In a related embodiment,the package is a corrugated element with side walls comprisingalternating ridges and grooves.

The alternating ridges and grooves may increase the flexibility of theside wall of the corrugated tubular element, compared with a tubularelement not having alternating ridges and grooves. In order to providethe package with a wall of flexible material, it may be provided as aside wall having alternating ridges and grooves in a radial direction ofthe central longitudinal axis of the package. This means that thethickness of the material may be increased in order to provide a moregas impermeable side wall, without having to compromise significantly onthe flexibility of the package.

The flexibility of the package may be approximately 200 MPa. Thereby thepackage will be flexible but without being too bendable. The thicknessof the package will for Polyethylene typically be between approximately0.5 mm and approximately 0.8 mm.

The catheter may be a regular intermittent urinary catheter with aninsertable length of approximately 80 mm to approximately 150 mm.Typically, the catheter will be provided with drainage eyelets at thetip end. Furthermore, the catheter will have an interior lumen totransport the urine from the tip to the connector end.

The catheter may be coated with a hydrophilic coating for provision of alow friction surface. A low friction surface reduces the risk ofmaceration of the internal walls of the urethra.

In an embodiment, the catheter may be packed for storage and/ortransport with a liquid swelling medium for wetting the hydrophiliccoating and for maintaining the hydrophilic coating in a fully hydratedstate during storage and/or transport. By arranging a liquid swellingmedium maintaining the hydrophilic coating in a fully hydrated stateduring storage and/or transport the user may be provided with a ready touse catheter that may be used directly after removing the telescopicdevice from its package. Furthermore, the user is not required to bringany accessories, such as lubricating gel or an external source of liquidswelling medium for the preparation of the catheter.

The rigidity of the catheter and the angle at the flared end may beselected so that the two properties in combination allow the flared endof the catheter to be bent in the direction towards the tip. This meansthat the flared end will be able to flip over. The ability to do that iscontrolled by both the rigidity of the material and the steepness of thetaper at the flared end. If the angle is very low compared to thelongitudinal direction of the catheter, the rigidity will need to bevery low to enable the end to flip over. If the angle is high (close to90 degrees), the rigidity can be much higher and still then end will beable to flip over.

Thus, the flared end of the catheter will be able to bend when subjectedto a pushing force exceeding a predetermined level. This level willtypically be around 4-10 N preferably 5 N for regular urinary catheters.The pushing force may be lower for thin catheters to be used forchildren and larger for the thickest types of catheters. This pushingforce corresponds to the force usually required for inserting cathetersinto urethras. When the level of force required getting the flared endto flip over is selected to correspond to the usual insertion force, theflared end and the protrusions of the package will function as a safetymeasure during insertion. If the pushing force at the catheter gets toohigh, the flared end will flip over and send a signal to the user thatthere may be a constriction or other problem during insertion. Thus theuser will be prevented from pushing too hard and thereby damaging theinternal mucosa of the urethra.

The rigidity (measured as flexural modulus) will typically be betweenapproximately 50 MPa and approximately 200 MPa.

The angle of the flared end with respect to the longitudinal directionmay be approximately 45 degrees. Values around 45 degrees are suitablefor a rather flexible catheter, that is a catheter having a flexuralmodulus in the lower end such as between 50 and 100 MPa. For a morerigid catheter, the angle should be steeper so it can be bent to face inthe opposite direction. For such a catheter, values of approximately 75degrees should be selected. The adaptation of the angle and the rigidityof the catheter are within the skills of a skilled person. Selecting anangle different from (lower than) 90 degrees has the effect that theforce required to remove the catheter from the package will be less thanthe force required to get the flared end to flip over so that thecatheter can be re-entered into the package.

The catheter may be made of a material such as Silicone or PolyUrethane.

The flared end of the catheter may be integral with the catheter.Alternatively, the flared end may be made as a separate element andattached to the catheter.

A flared end integral with the catheter is easy and fast to manufacture,because the catheter and flared end can be manufactured in fewer steps.The catheter will be extruded from the tip. Following that the end willbe heated and during the heating process the end will be flared. This isone way of forming the catheter, however other ways are also possible.

The internal ribs of the package are made of the same material as thepackage. The material must be relatively, it should at least be morerigid than the flared end to be able to provide a force to the flaredend.

The number of ribs can be anything between 4 and 20. For most users,approximately 10 ribs will be enough to provide the insertion aid. Theribs are at least approximately 0.2 mm in the direction extending outfrom the wall of the package. This corresponds to the thickness of thecatheter and is thus enough to provide a backstop function.

When the package is helically shaped, the ribs need only be present inthe outermost wall of each winding. This is because the catheter willseek to unfold itself to a straight configuration, thereby causing theflared end to be in contact with the outermost wall of each windingwhile the catheter is removed from the package.

The package may function as an insertion guide for the catheter. This ispossible because the ribs of the package function as a stopper for thecatheter and prevent it from being pushed back into the package.

Due to close-fitting the urine exiting the catheter is prevented fromexiting the package in the front end of the package.

The package may be provided with means for preventing the catheter to becompletely removed from the package. Thus the catheter kit has aposition in which the catheter is fully extended. The means forpreventing complete removal may be in form of larger ribs extendingtransversely into the package from the wall. For a spiral shapedpackage, a cavity may be provided into which the flared end fits. Thiscavity may have an extension to an outlet from the package.

When a catheter kit, as previously described, is used, the urine maystart flowing before the catheter is fully extended to the proximal endof the package. For an elongated package, this is not a problem becausethe urine flows along the length of the package and exits at the distalend. However, for a spiral-shaped package, this may be a problem ifurine flow commences before the flared end is fitted in the cavity. Onlyin this position, will the urine flow to the outlet from the package. Ifthe flared end is within the spiral shape the urine will end up in thecentre of the spiral. To overcome this, the package may be provided witha by-pass for letting urine pass from the centre to the outlet from thepackage. This by-pass may be in form of a channel extending across thespiral. However, other solutions are also possible, such as a tube.

BRIEF DESCRIPTION OF THE DRAWING

FIGS. 1 and 2 illustrate a catheter with a flared end.

FIG. 3 illustrates one embodiment of a package.

FIG. 4 illustrates another embodiment of a package.

FIGS. 5 a and 5 b illustrate a kit comprising a catheter and a package.

DETAILED DESCRIPTION OF THE DRAWING

The invention is now explained more in detail with reference to thedrawings showing preferred embodiments of the invention. However, itshould be understood that the detailed description and specificexamples, while indicating at least one preferred embodiment of theinvention, are given by way of illustration only, since various changesand modifications within the spirit and scope of the invention willbecome apparent to those skilled in the art from this detaileddescription.

FIGS. 1 and 2 illustrate a catheter 1 with a flared end 2 that formspart of a kit (not shown in this figure) according to the invention. InFIG. 1, the catheter 1 is illustrated in cross-section, and in FIG. 2 aphotograph of the distal end of the catheter is shown. The cathetercomprises a tubular element with a proximal end 3 and a distal end 4. Inthe proximal end 3 (the insertion end), there are eyelets 5. In FIG. 1,two eyelets 5 are shown—however, there may be only one eyelet or morethan two eyelets. The flared end 2 is provided in the distal end 4. Thedrawing in FIG. 1 is not to scale; a urinary catheter (particularly formales) will typically be longer compared to the width. FIG. 1 alsoillustrates the angle theta θ between the flared end and the remainderof the catheter.

FIG. 3 illustrates a package 20 that may be used in a kit according tothe invention. This package 20 is a package with a spiral-shaped storagespace 21 for a catheter defined by spiral-shaped walls 22. Thespiral-shaped storage space 21 commences at an inner periphery 23 nearthe centre of the package and terminates at the outer periphery 24. Atthe termination, the package 21 is provided with a cavity 25 adapted forreceiving the connector of a catheter, when the catheter is fullyextended. In this position, the connector from a catheter willcommunicate with an outlet 26 from the package through a channel 27connecting the outlet 26 and the cavity 25. The channel 27 may just be ahole in the wall 22 defining the storage space 21. The outlet 26 may beshaped as a tapered outlet so that it defines a receiving space for aconnection to a tube.

The package 20 may further be provided with a by-pass 28 connecting thecentral storage space 29 at the centre 23 of the package with the outlet26. As described earlier, such a by-pass allows urine, which has enteredinto the storage space 21, to exit the storage space 21 through theby-pass 28 and the outlet 26. The by-pass may be in the form of holes inthe spiral-shaped walls 22.

FIG. 4 illustrates another type of package 30 that may form part of akit according to the invention. This type of package 30 comprises astorage space 31 inside a tubular corrugated element 32. A corrugatedpackage 30 allows the package including the catheter to be folded orrolled into a more compact figuration, as shown in the figure.

FIGS. 5A and 5B illustrates a kit 40 according to the invention. The kit40 includes a corrugated package 30 as in FIG. 4 in combination with acatheter 1 as in FIG. 1. The catheter has a flared end 2 with an outerdiameter slightly larger than the smallest inner diameter of the package30 as shown in FIG. 5B. In FIG. 5A the flared end 2 of the catheter iscompressed slightly as it passes one of the corrugations in the package30. If the catheter is pulled out of the package, that is, in thedirection of the arrow in the drawing, then the flared end 2 will becompressed slightly as it passes each corrugation. When the user triesto push the catheter into the package, in the direction against thearrow, then the flared end 2 will be caught against one of thecorrugations and initially resist the pushing. If the pushing forceexceeds a certain level (5-10 N) the flared end 2 will turn so it facesin the direction of the tip of the catheter, and the user will be ableto push the catheter into the package.

The invention being thus described, it will be apparent that the samemay be varied in many ways. Such variations are not to be regarded as adeparture from the spirit and scope of the invention, and all suchmodifications as would be recognized by one skilled in the art areintended to be included within the scope of the following claims.

The invention claimed is:
 1. A kit of parts comprising: a urinarycatheter having a tubular section sized to a first diameter and attachedbetween a proximal end insertable into a bladder and a flared distal endhaving a diameter that is wider than the first diameter; a packageincluding a storage space provided to retain the urinary catheter, thestorage space is defined by a wall organized in a spiral pattern with aspace provided between the wall and an adjacent portion of the wallorganized in the spiral pattern, the space is sized to receive the firstdiameter of the tubular section and the flared distal end of the urinarycatheter in sliding engagement, and the spiral pattern terminates at anouter periphery of the package; a cavity formed in an outer periphery ofthe package, and the spiral pattern terminates at the cavity formed inthe outer periphery of the package; and an outlet provided separatelyfrom the cavity, with a channel connecting the outlet and the cavity,and the outlet provided to allow urine to exit the package; wherein thespiral pattern is configured to ensure contact between the flared distalend and the wall that is organized in the spiral pattern to thus preventthe urinary catheter from being pushed back into the storage spaceduring insertion of the urinary catheter into the bladder; wherein thecavity is sized to prevent the flared distal end of the urinary catheterfrom exiting the package.
 2. The kit of parts according to claim 1,wherein the package is made of a material that is gas impermeable. 3.The kit of parts according to claim 1, wherein the urinary catheter iscoated with a hydrophilic coating providing a low friction surface. 4.The kit of parts according to claim 3, wherein the urinary catheter isfurther provided with a liquid for wetting the hydrophilic coating andfor maintaining the hydrophilic coating in a fully hydrated state duringstorage transport.
 5. The kit of parts according to claim 1, wherein theflared distal end of the urinary catheter is integral with the urinarycatheter.
 6. The kit of parts according to claim 1, wherein the flareddistal end is a separate element attached to the urinary catheter. 7.The kit of parts according to claim 1, wherein the outlet is tapered todefine a receiving space for a connector that is adapted for connectionto the flared distal end of the urinary catheter.
 8. The kit of partsaccording to claim 1, wherein the wall is provided with ribs that extendoutward from the wall.
 9. The kit of parts according to claim 8, whereinthe number of ribs is between 4 and
 20. 10. The kit of parts accordingto claim 1, wherein the package includes a urine by-pass formed in thewall and communicating with the outlet.
 11. The kit of parts accordingto claim 10, wherein the urine by-pass includes a plurality of holesformed in the wall.